Several large prospective studies have shown that active surveillance (AS) is an effective strategy to postpone or even prevent radical treatment and its associated morbidity in patients diagnosed with prostate cancer, without compromising disease prognosis.1-3 However, these studies all use strict inclusion criteria and thus mainly describe outcomes of patients with (very) low-risk disease.
A major issue related to active surveillance (AS) regards the extent to which eligibility criteria may be expanded. Outweighing the advantages of potentially avoiding radical treatment and associated morbidity against the risk of the tumour progressing to a stage with worse prognosis remains the most important dilemma when selecting (higher-risk) patients for AS. To support clinicians and patients in their (shared) decision-making, more data is necessary regarding the prognosis of higher risk patients on AS.
In this study, we evaluated a real-world cohort of AS patients who initiated AS between 2008 and 2014 at the Santeon hospital consortium.4 We found that half of the patients on AS were higher risk patients and did not meet the inclusion criteria of the PRIAS study, the largest ongoing AS study to date.1 This shows that in daily practice, eligibility criteria for AS are already being expanded.
The described outcomes of this relatively large number of higher risk patients provide valuable information regarding the prognosis of this subpopulation, and a number of lessons may be learned. For instance, patients who did not meet PRIAS inclusion criteria had significantly earlier disease progression compared to PRIAS eligible patients (median AS time 3.7 years vs. 6.4 years). Also, a high PSAD (>0.20) was predictive for a higher risk of metastasis (HR: 2.7, 95%CI 1.2 – 6.0). Lastly, given the fact we observed a high rate of metastases (7/57, 12%) among patients with a high PSAD (>0.20) and more than two positive biopsy cores at baseline, AS may not be a safe option for patients with these risk factors.
In conclusion, we believe our study results provide relevant insights regarding patient selection for AS in the real-world clinical situation. Moreover, the outcomes described in this study are relevant for daily practice as they help patients and their treating clinicians decide whether or not AS is the right option given their baseline risk factors and individual preferences.
Written by: Timo Soeterik, MD, PhD, Candidate at the Santeon Hospital Consortium, Utrecht, the Netherlands. Email:
1. Bokhorst LP, Valdagni R, Rannikko A, Kakehi Y, Pickles T, Bangma CH, et al. A Decade of Active Surveillance in the PRIAS Study: An Update and Evaluation of the Criteria Used to Recommend a Switch to Active Treatment. Eur.Urol. 2016.
2. Tosoian JJ, Mamawala M, Epstein JI, Landis P, Wolf S, Trock BJ, et al. Intermediate and Longer-Term Outcomes From a Prospective Active-Surveillance Program for Favorable-Risk Prostate Cancer. J.Clin.Oncol. 2015;33 3379-85.
3. Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, et al. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J.Clin.Oncol. 2015;33 272-7.
4. Soeterik TFW, van Melick HHE, Dijksman LM, Biesma DH, Witjes JA, van Basten JA. Active Surveillance for Prostate Cancer in a Real-life Cohort: Comparing Outcomes for PRIAS-eligible and PRIAS-ineligible Patients. European Urology Oncology 2018;1 231-7.